Skip to main content
release_alert
Welcome to the new Scholars 3.0! Read about new features and let us know what you think.
cancel
Journal cover image

First prospective clinical trial of reduced incision bariatric procedures using magnetic liver retraction.

Publication ,  Journal Article
Luengas, R; Galindo, J; Castro, M; Marambio, A; Watkins, G; Rodriguez Del Rey, M; Davanzo, C; Portenier, D; Guerron, AD
Published in: Surg Obes Relat Dis
January 2021

BACKGROUND: Exposure of the surgical field is an essential component of minimally invasive surgery. Liver retraction is an important element of bariatric procedures because visualization of the stomach and gastroesophageal junction is key. The magnetic surgical system provides a well-tolerated and effective option for adjustable liver retraction without the use of a dedicated port. OBJECTIVE: The purpose of this study was to evaluate the safety profile and effectiveness of the magnetic surgical system in patients undergoing bariatric procedures. SETTING: Two investigational sites in Chile. METHODS: A prospective, single-arm study (ClinicalTrials.govNCT03508674) with adherence to Good Clinical Practices and ISO 14155:2011(E) was undertaken to evaluate the safety profile and effectiveness of the magnetic surgical system in patients undergoing bariatric surgery. Patient follow-up occurred at 7 and 30 days postprocedure. RESULTS: A total of 50 patients who met the inclusion criteria had a body mass index ranging from 28.4 to 58.2 kg/m2. All procedures were completed without complications or conversions. The average overall procedure time was 61 minutes, and the amount of coupling time between the magnetic controller and the detachable grasper was 37 minutes. In all cases the device was able to adequately retract the liver to achieve an effective exposure of the target tissue and perform the bariatric procedure. A total of 24 adverse effects were reported throughout the course of the study. All device-related adverse effects were mild in severity and resolved with no clinical sequelae. CONCLUSION: The magnetic surgical system is a well-tolerated and effective option for liver retraction in minimally invasive and bariatric surgery in patients with a varying range of body mass indexes.

Duke Scholars

Published In

Surg Obes Relat Dis

DOI

EISSN

1878-7533

Publication Date

January 2021

Volume

17

Issue

1

Start / End Page

147 / 152

Location

United States

Related Subject Headings

  • Surgery
  • Prospective Studies
  • Obesity, Morbid
  • Magnetic Phenomena
  • Liver
  • Laparoscopy
  • Humans
  • Chile
  • Bariatric Surgery
  • 1117 Public Health and Health Services
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Luengas, R., Galindo, J., Castro, M., Marambio, A., Watkins, G., Rodriguez Del Rey, M., … Guerron, A. D. (2021). First prospective clinical trial of reduced incision bariatric procedures using magnetic liver retraction. Surg Obes Relat Dis, 17(1), 147–152. https://doi.org/10.1016/j.soard.2020.08.017
Luengas, Rafael, Jose Galindo, Melissa Castro, Andres Marambio, Guillermo Watkins, Mario Rodriguez Del Rey, Cristobal Davanzo, Dana Portenier, and Alfredo D. Guerron. “First prospective clinical trial of reduced incision bariatric procedures using magnetic liver retraction.Surg Obes Relat Dis 17, no. 1 (January 2021): 147–52. https://doi.org/10.1016/j.soard.2020.08.017.
Luengas R, Galindo J, Castro M, Marambio A, Watkins G, Rodriguez Del Rey M, et al. First prospective clinical trial of reduced incision bariatric procedures using magnetic liver retraction. Surg Obes Relat Dis. 2021 Jan;17(1):147–52.
Luengas, Rafael, et al. “First prospective clinical trial of reduced incision bariatric procedures using magnetic liver retraction.Surg Obes Relat Dis, vol. 17, no. 1, Jan. 2021, pp. 147–52. Pubmed, doi:10.1016/j.soard.2020.08.017.
Luengas R, Galindo J, Castro M, Marambio A, Watkins G, Rodriguez Del Rey M, Davanzo C, Portenier D, Guerron AD. First prospective clinical trial of reduced incision bariatric procedures using magnetic liver retraction. Surg Obes Relat Dis. 2021 Jan;17(1):147–152.
Journal cover image

Published In

Surg Obes Relat Dis

DOI

EISSN

1878-7533

Publication Date

January 2021

Volume

17

Issue

1

Start / End Page

147 / 152

Location

United States

Related Subject Headings

  • Surgery
  • Prospective Studies
  • Obesity, Morbid
  • Magnetic Phenomena
  • Liver
  • Laparoscopy
  • Humans
  • Chile
  • Bariatric Surgery
  • 1117 Public Health and Health Services